A Study of a New Vaccine Against Two Types of Ebola (NCT05079750) | Clinical Trial Compass
CompletedPhase 1
A Study of a New Vaccine Against Two Types of Ebola
United Kingdom26 participantsStarted 2021-11-11
Plain-language summary
An open-label, non-randomised, dose escalation, first-in-human, single centre, phase I clinical trial to determine the safety and immunogenicity of a bivalent ChAdOx1 vectored vaccine against Zaire and Sudan Ebola virus species in healthy adult volunteers.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy adults aged 18 to 55 years.
✓. Able and willing (in the Investigator's opinion) to comply with all study requirements.
✓. Willing to allow confirmation of their past medical history either through: provision of a GP medical record summary, allowing investigators to obtain a copy of their medical history from their GP practice or by providing an alternative acceptable means of confirming their past medical history.
✓. Agreement to refrain from blood donation during the course of the study.
✓. Provide written informed consent.
✓. For women of childbearing potential only: Willingness to practice continuous effective contraception for the duration of the trial.
✓. For women of childbearing potential only: A negative pregnancy test on the day of both screening and vaccination.
Exclusion criteria
✕. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period.
✕. Receipt of a recombinant simian adenoviral vaccine prior to enrolment.
✕. Planned receipt of another adenoviral vectored vaccine (e.g. Oxford/AstraZeneca or Janssen COVID-19 vaccines) within 90 days after the vaccination with the ChAdOx1 biEBOV.
✕. Planned or actual receipt of any vaccines administered within 30 days (before or after) enrolment and/or planned receipt of a vaccine ≤30 days after enrolment EXCEPT for protein, RNA (or other non-adenovirus based) COVID-19 vaccinations which may be given within 14 days of the trial vaccine.
What they're measuring
1
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms
Timeframe: 7 days following vaccination
2
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms
Timeframe: 28 days following vaccination
3
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Serious Adverse Events
Timeframe: Duration of the study (6 months)
4
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities
✕. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
✕. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) systemically active immunosuppressant medication within the past 6 months.
✕. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Including hypersensitivity to the active substance or to any of the excipients of the IMP or Vaxzevria (i.e. the Oxford/AstraZeneca COVID-19 vaccine).